meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
40
Latest Decision
2016-11-15

Clearances · page 49 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K161753 Hoffman LRF System Stryker GmbH KTT Class II 2016-11-15
K161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc. PHX Class II 2016-11-15
K153656 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. OUR Class II 2016-11-14
K162576 FORTEZZA Spinal Stabilization System Osso Surgical NKB Class II 2016-11-10
K161417 DePuy Synthes MAXFRAME Multi-Axial Correction System Synthes USA, LLC KTT Class II 2016-11-10
K162262 Tritanium® PL Cage Stryker MAX Class II 2016-11-09
K161610 EXPRT Revision Hip System Encore Medical L.P. KWZ Class II 2016-11-09
K161649 Virtu C Spinal Implant System Met 1 Technologies, LLC ODP Class II 2016-11-09
K161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion System Genesys Spine MAX Class II 2016-11-08
K160924 Amendia Interbody Fusion Devices Amendia, Inc. MAX Class II 2016-11-08
K160446 MCP Bone Putty Biostructures, LLC MQV Class II 2016-11-07
K162273 Materialise TKA Guide System Materialise NV JWH Class II 2016-11-07
K161254 Renovo Life Small Bone IM Nail System Renovo Life, LLC HSB Class II 2016-11-07
K162944 Irix-C Cervical Integrated Fusion System X-Spine Systems, Inc. OVE Class II 2016-11-07
K161703 LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer Aap Implantate AG HRS Class II 2016-11-04
K161913 AOS Small Fragment Plating System Advanced Orthopaedic Solutions, Inc. (Aos) HRS Class II 2016-11-04
K161592 Persona Partial Knee System Biomet, Inc. HSX Class II 2016-11-03
K162801 CastleLoc Spinal Fixation System L&K BIOMED Co., Ltd. MNH Class II 2016-11-03
K162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System L&K BIOMED Co., Ltd. NKG Class II 2016-11-03
K161174 Nanova Interference Screw Nanova Biomaterials, Inc. MAI Class II 2016-11-03
K161590 MatrixRIB Fixation System Synthes (USA) Products, LLC HRS Class II 2016-11-03
K162453 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) Pan Medical , Ltd. NDN Class II 2016-11-01
K160895 Initia Total Hip System & BIOCERAM AZUL(R) HEAD Kyocera Medical Corporation LZO Class II 2016-11-01
K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System Synthes USA Products, LLC MAX Class II 2016-11-01
K162062 AVAmax Vertebral Balloon, AVAflex Vertebral Balloon Stryker Corporation HRX Class II 2016-11-01
K161620 Anatomical Shoulder Domelock Dome centric Zimmer GmbH HSD Class II 2016-11-01
K161448 Footmotion Plating System Newclip Technics HRS Class II 2016-10-31
K162419 FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. PQC Class II 2016-10-28
K161520 ELEOS Limb Salvage System Onkos Surgical, Inc. KRO Class II 2016-10-28
K162422 Klassic Knee System Total Joint Orthopedics, Inc. JWH Class II 2016-10-28
K162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene SeaSpine Orthopedics Corporation MAX Class II 2016-10-28
K162367 Erisma® LP MIS Clariance, Sas NKB Class II 2016-10-27
K162256 Klassic Femur, Porous, Klassic Tibial Baseplate, Porous Total Joint Orthopedics, Inc. MBH Class II 2016-10-27
K162750 Libra Pedicle Screw System Spinal Balance, Inc. NKB Class II 2016-10-27
K161830 Zimmer M/L Taper Hip Prosthesis Zimmer, Inc. LZO Class II 2016-10-26
K162138 NuVasive CoRoent Small Ti-C System Nu Vasive, Incorporated ODP Class II 2016-10-26
K161351 NanoBone SBX Putty Artoss GmbH MQV Class II 2016-10-26
K162250 FortiBridge Anterior Cervical Plate System Nanovis Spine, LLC KWQ Class II 2016-10-26
K162386 KATOR Suture Anchor Kator, LLC MBI Class II 2016-10-25
K161426 NeoSpan Compression Staple Impant w/instruments In2bones USA, LLC JDR Class II 2016-10-24
K160313 Xenco Medical Cervical Interbody System Xenco Medical, LLC OVE Class II 2016-10-21
K162061 M.U.S.T. Pedicle Screw System Medacta International S.A. NKB Class II 2016-10-21
K162635 Distal Radius Plating System Miami Device Solutions, LLC HRS Class II 2016-10-21
K160352 MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. PGN Class II 2016-10-21
K161073 Klassic HD Hip System Total Joint Othopedics, Inc. LPH Class II 2016-10-19
K161016 Z-Clamp ISP System Zavation, LLC PEK Class II 2016-10-19
K160074 Rampart D Lumbar Interbody Fusion Device Spineology, Inc. MAX Class II 2016-10-18
K161184 iNSitu Total Hip System Theken Companies, LLC LPH Class II 2016-10-14
K161569 Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics LPH Class II 2016-10-14
K161842 Overwatch Spine System Amendia, Inc. NKB Class II 2016-10-13
K160076 XCage™ Interbody Fusion System Ouroboros Medical, Inc. MAX Class II 2016-10-13
K162424 Ulna Plating System Biomet, Inc. HRS Class II 2016-10-12
K161449 HammerTech Fixation System Fusion Orthopedics, LLC HWC Class II 2016-10-11
K161642 CAVUX™ Cervical Cage Providence Medical Technology, Inc. ODP Class II 2016-10-07
K162664 Pyrenees Cervical Plate System K2m, Inc. KWQ Class II 2016-10-07
K160174 I.B.S. 2.0 Osteosynthesis screw In2bones Sas HWC Class II 2016-10-06
K161447 HydroSet XT Orthovita, Inc. MQV Class II 2016-10-06
K160731 LumFix Spinal Fixation Sytem CG Bio Co., Ltd. MNI Class II 2016-10-04
K162494 CD HORIZON® Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2016-10-04
K161608 InterForm Cervical Interbody Cage System Next Orthosurgical ODP Class II 2016-09-30
K162426 nva, nvp, and nvt Nvision Biomedical Technologies, LLC MAX Class II 2016-09-29
K161379 ELSA Spacers Globus Medical, Inc. OVD Class II 2016-09-29
K161173 Avenue® T TLIF Cage Ldr Spine USA, Inc. OVD Class II 2016-09-28
K161014 NuVasive® Reline® System Nu Vasive, Incorporated NKB Class II 2016-09-28
K161442 NuVasive® CoRoent® Small Interlock™ System Nu Vasive, Incorporated OVE Class II 2016-09-28
K162307 OrthoPediatrics Locking Proximal Femur System Cortical Screws OrthoPediatrics Corp. HRS Class II 2016-09-27
K160167 DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC HSB Class II 2016-09-26
K161878 PORTAGE System Baylis Medical Company, Inc. HRX Class II 2016-09-26
K160640 PASS XS Spinal System Medicrea International SA NKB Class II 2016-09-23
K162143 FixxSure® X-Link Innovasis, Inc. MNH Class II 2016-09-23
K161945 EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) Encore Medical L.P. JWH Class II 2016-09-23
K161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments Globus Medical, Inc. NKG Class II 2016-09-21
K161746 ARIX Hand System Jeil Medical Corporation HRS Class II 2016-09-21
K162264 Cascadia Interbody System K2m, Inc. MAX Class II 2016-09-21
K161151 Spinal fixation system Canwell Medical Co., Ltd. MNH Class II 2016-09-21
K161489 Syntorr K-wire and Pin System Syntorr, Inc. HTY Class II 2016-09-16
K162475 mi-eye 2, mi-eye 2 monitor Trice Medical HRX Class II 2016-09-16
K153665 PROW FUSION-L Nlt Spine, Ltd. MAX Class II 2016-09-15
K161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SeaSpine Orthopedics Corporation OVE Class II 2016-09-14
K161888 JULIET® LL Lateral Lumbar Cage Spineart MAX Class II 2016-09-12
K161876 Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. JDQ Class II 2016-09-09
K160958 Battalion Universal Spacer System Alphatec Spine PHM Class II 2016-09-08
K153302 coflex-IF Paradigm Spine, LLC PEK Class II 2016-09-08
K161535 SeaSpine® NewPort™ Spinal System SeaSpine Orthopedics Corporation NKB Class II 2016-09-08
K161166 StageOne Select Cement Spacer Molds for Temporary Hip Replacement Biomet, Inc. MBB Class II 2016-09-08
K153609 RTS Flexible 1 MPJ Implant w/Grommets In2bones USA, LLC KWH Class II 2016-09-08
K161129 PILLAR SA PTC Orthofix, Inc. OVD Class II 2016-09-08
K153207 Additive Orthopaedics Bone Wedge System Additive Orthopaedics, LLC HRS Class II 2016-09-07
K162222 GENflex2 Total Knee System Stelkast, Inc. JWH Class II 2016-09-07
K161478 Xenco Medical Posterior Cervical System Xenco Medical, LLC NKG Class II 2016-09-06
K161485 Nanovis Intervertebral Body Fusion System and Forticore(R) Nanovis, LLC MAX Class II 2016-09-06
K160159 Active-X Total Knee System Signature Orthopaedics Pty, Ltd. JWH Class II 2016-09-06
K160698 LigaPASS Medicrea International SA OWI Class II 2016-09-02
K160066 Pro-Link® Stand-Alone Cervical Spacer System Life Spine, Inc. OVE Class II 2016-09-02
K161524 Tangis Anterior Cervical Plate Nvision Biomedical Technologies, LLC KWQ Class II 2016-09-02
K161751 MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. PGN Class II 2016-09-02
K153649 Exactech® Novation® Element Press-fit Femoral Stem Exactech, Inc. MEH Class II 2016-08-31
K162189 ANAX™ 5.5 Spinal System U&I Corporation MNH Class II 2016-08-30
K160597 INDEPENDENCE MIS Spacers Globus Medical, Inc. OVD Class II 2016-08-29
K161108 Arthrex VaultLock Glenoid Arthrex, Inc. KWS Class II 2016-08-29

17,115 clearances in the Orthopedic panel. Data: openFDA.